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Efficacy and Safety of Fecal Microbiota Transplantation for Chronic Intestinal Pseudo-obstruction

Efficacy and Safety of Fecal Microbiota Transplantation in Treatment of Chronic Intestinal Pseudo-obstruction: a Preliminary Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02731183
Enrollment
9
Registered
2016-04-07
Start date
2014-12-31
Completion date
2016-03-31
Last updated
2017-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Intestinal Pseudo Obstruction

Keywords

Fecal Microbiota Transplantation, Chronic intestinal pseudo obstruction, Efficacy and safety

Brief summary

Chronic intestinal pseudo obstruction(CIPO) is a serious motility disorder with life-threatening condition, and it is often related with bacterial overgrowth. Fecal microbiota transplantation (FMT) results in restoration of the normal intestinal microbial community structure. The investigators planned to observe the efficacy of FMT in the treatment of a series CIPO patients. Patients received FMT on 6 consecutive days through nasojejunal tubes and followed up for 8 weeks after treatment. Rate of clinical improvement and remission, feeding tolerance of enteral nutrition, CT score of intestinal obstruction, and gastrointestinal quality-of-life index(GIQLI) were evaluated.

Interventions

PROCEDUREfecal microbiota transplantation

Patients received frozen FMT on 6 consecutive days through nasojejunal tubes.

Sponsors

Jinling Hospital, China
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients had to have a firm diagnosis diagnostic criteria for CIPO proposed by Ministry of Health, Labour, and Welfare, including documented pathological bowel dilatation on imaging in the absence of mechanical obstruction.

Exclusion criteria

None.

Design outcomes

Primary

MeasureTime frameDescription
the tolerance of enteral nutrition (EN) through nasojejunal tube8 weeksWe defined feeding intolerance (FI) as inability to deliver the amount of nutrient as a proportion of 'energy requirements', with values of 80% chosen, or a certain amount (750ml) per 24h.
the time oral intake started8 weeksThe time when oral intake (both fluids and solid food) started was noted.

Secondary

MeasureTime frameDescription
symptomatic relief8 weeksThe occurrence and severity of each of these symptoms: pain, nausea, vomiting and bloating (each scored as 0 = absent, 1 = mild, 2 = medium, 3 = severe, or 4 = could not be worse) were recorded by nurses blinded to the intervention on a daily basis.
scoring evaluation of abdominal CT8 weeksWe use a computed tomography scoring system to evaluate the severity of obstruction.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026